AVOID BAND-AID SOLUTIONS Strengthening Adverse Event Investigations Presenters: Mary Ludlum Melissa Parkerton Lynn Trexler
OUR MISSION Reduce the risk of serious adverse events occurring in Oregon s healthcare system and encourage a culture of patient safety
Who We Are Separate from regulatory agencies 17-member board appointed by Governor and confirmed by Legislature (representing diverse healthcare interests, including consumers) Funded by fees assessed on Oregon healthcare organizations, state general funds, and grants supporting mission-appropriate work 3
Oregon Patient Safety Commission Improve patient safety by reducing the risk of serious adverse events occurring in Oregon s healthcare system and by encouraging a culture of patient safety ( 442.820) Patient Safety Reporting Program Early Discussion and Resolution Quality Improvement and Disseminating Best Practices 4
What motivates your patient safety work? 5
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Today s Objectives Review basics of patient safety and adverse events Demonstrate how to collect and organize the facts Identify system-level contributing factors using cause-effect diagram Identify root causes using the 5 Whys Develop strong, system-level action plans Use PDSA and Model for Improvement for implementation strategies 7
Melissa Parkerton BASICS OF PATIENT SAFETY AND ADVERSE EVENTS 8
How many preventable deaths are happening just in hospitals each year? 9
Preventable Deaths 1999 44,000 98,000 Kohn, L. T., Corrigan, J., & Donaldson, M. S. (2000). To err is human: Building a safer health system. Washington, D.C: National Academy Press. 2003 210,000 400,000 2016 250,000 James, J.T. (2013). A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care. Journal of Patient Safety, 9(3): 122-128. Makary, M.A. (2016). Medical error the third leading cause of death in the US. BMJ, 353(i2139). safety issues are far more complex and pervasive than initially appreciated. National Patient Safety Foundation. (2015). Free from Harm: Accelerating Patient Safety Improvement Fifteen Years After To Err is Human. 10
Adverse Events An event resulting in unintended harm or creating the potential for harm that is related to any aspect of a patient's care (by an act of commission or omission) rather than to the underlying disease or condition of the patient. Adverse events may or may not be preventable. 11
Systems Approach Individual Blame and Shame Systems Approach Focus on human factors engineering (e.g., design of protocols, processes) 12
James Reason s Swiss Cheese Model Successive layers of defenses, barriers, and safeguards Some holes due to active failures and others are due to latent conditions Sources: Skybrary; Institute for Healthcare Improvement 13
Unsafe Acts Slip Mistake Normalized Deviance An action doesn t go as intended (an inadvertent, unconscious lapse when performing an automatic process) An action goes as intended but is the wrong one (a result from incorrect choices due to lack of knowledge, experience or training) Little problems that crop up in our daily routine become so familiar that we start assuming they re completely normal 14
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Culture of Safety Culture of safety: the attitudes, perceptions, and values that employees share in relation to safety Characteristics of a strong culture of safety: Psychological safety. Concerns openly received and respected Active leadership. Leaders create environment where all staff are comfortable expressing their concerns Transparency. Patient safety problems aren t swept under the rug; organizations learn from problems to improve the system Fairness. People know they will not be punished or blamed for system-based errors Source: Institute for Healthcare Improvement 16
AHRQ Surveys on Patient Safety Culture Ambulatory surgery center survey Community pharmacy survey Hospital survey Nursing home survey 17
What is a Root Cause Analysis (RCA)? A structured team process to identify the underlying cause(s) that increase the likelihood of errors within a process Also called systems analysis (Agency for Healthcare Research and Quality) or Comprehensive Systematic Analysis (The Joint Commission) 18
Why a RCA? To determine What happened Why it happened What changes need to be made 19
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Lynn Trexler CONDUCTING REVIEWS: TIMELINE, CAUSE-EFFECT DIAGRAM, CONTRIBUTING FACTORS 21
What Should I Review? Any unanticipated, usually preventable event that results in patient harm Any serious adverse events that result in patient death or serious injury Specific event type lists for each reporting entity are available on OPSC s website (e.g., surgical events, device events, retained objects, falls, and medication errors) 22
Prioritizing Reviews Aggregated review of similar, high frequency close call events E.g., falls or medication events can be reviewed quarterly to identify themes and potential system fixes Safety Assessment Code (SAC) Matrix Allows you to assign a numeric scores based on the probability and severity of an event Evaluates what actually happened as well as worst case scenarios based on potential harm http://www.npsf.org/?page=rca2 23
SAC Numeric Scores Severity Catastrophic. Actual or potential death or major permanent loss or function Major. Actual or potential permanent lessening of bodily function Moderate. Actual or potential increase length of stay or level of care Minor. No injury, nor increased length of stay or level of care Probability Frequent. likely to occur immediately or within a short period of time (may happen several times in the next year) Occasional. Probably will occur (may happen several times in 1 to 2 years) Uncommon. Possible to occur (may happen sometime in 2 to 5 years) Remote. Unlikely to occur (may happen sometime in the next 5 to 30 years) 24
SAC Matrix A score of 3 (highest risk) warrants review, whereas scores of 1 (lowest risk) or 2 (intermediate risk) are not mandated Catastrophic events are always a 3 and therefore reviewed 25
Care Delay Event Severity = catastrophic Probability = frequent Score = 3 26
Surgery/Procedural Event Severity = moderate Probability = frequent Score = 2 27
Step 1: Gather the Data Interview those involved including patient/resident or family members and staff Use open ended questions (e.g., Please tell me, from your perspective, what happened before you fell or before you received the wrong medicine?) Listen to their story Pictures or drawings of the scene or inspections of the environment Relevant policies or procedures Devices, supplies or equipment involved 28
System versus Individual Causes Individual System Knowledge Understanding Behavior Procedure Practice Processes 29
Step 2: Select the Review Team Select review team members with personal knowledge of the processes and systems involved in the event as well as those who will need to be engaged in the action plan Focus away from individuals (who did it) to the system (how/why/where) 30
Review Team Patient representative Direct care staff Nurse(s) Management Providers Rehab staff/social services/nutrition Pharmacist 31
Review Team Considerations Able to discuss and review what happened in an objective and unbiased manner Keep the number of management or supervisory individuals to a minimum so staff feel comfortable speaking up Clarify that the discussion is confidential and information shared is not punishable 32
Step 3: Describe What Happened Collect and organize the facts surrounding the event to understand what happened 33
Mike s Story 34
Mapping Out Your Timeline Recovering from anesthesia Ready for discharge Trying to get dressed Mike falls 35
Mike s Perspective I was done with my surgery and I was ready to go home I was sitting in a chair and the nurse said to get dressed I needed to pull up my pants I fell when I stood up 36
Nurse s Perspective I reviewed the discharge packet with Mike and his wife; his wife went to get the car and Mike needed to get dressed Mike wanted privacy getting dressed, so I told him not to stand up because he might fall I heard Mike holler when I was getting my other patient ready to go Mike falls 37
Administrator s Perspective Mike was a frequent and familiar patient so assumed he and his wife knew the drill and that this nurse could assume care for an additional patient Other nurse assigned to this unit had to leave early due to sick child; this nurse took over care of other patient ready for discharge This nurse left Mike unattended Mike falls 38
What Should Have Happened? Patient assessed to be ready for discharge RN assists patient to get dressed Family member goes to get car RN takes patient to car Patient assessed to be ready for discharge RN instructs patient to get dressed and leaves unattended Family member goes to get car Patient falls 39
Step 4: Identify Contributing Factors Communication Device or Supply Human and Environmental Organizational Policy or Procedure Patient/Resident Management 40
Mike s Perspective Miscommunication I was done with my surgery and I was ready to go home I was sitting in a chair and the nurse said to get dressed I needed to pull up my pants I fell when I stood up 41
Nurse s Perspective Clarity of policy and procedure and patient assessment Personnel stress (caring for 2 patients) I reviewed the discharge packet with Mike and his wife; his wife went to get the car and Mike needed to get dressed Mike wanted privacy getting dressed, so I told him not to stand up because he might fall I heard Mike holler when I was getting my other patient ready to go Mike falls 42
Administrator s Perspective Assignment/ work allocation Staffing levels Mike was a frequent and familiar patient so assumed he and his wife knew the drill and that this nurse could assume care for an additional patient Other nurse assigned to this unit had to leave early due to sick child; this nurse took over care of other patient ready for discharge This nurse left Mike unattended Mike falls 43
Picture of the Area 44
Cause-Effect Diagram Communication Device/Supply Human or Environmental Work area design Patient Assignment/work allocation Clarity of P & P Personnel stress Patient assessment Patient fell while getting dressed Staffing levels Organizational Policy/Procedure Patient Management 45
Charlie s Story 46
Charlie s Story: Timeline Exercise: 20 minutes Read Charlie s Story Plot out the timeline Identify the contributing factors Miscommunication Recovering from anesthesia Ready for discharge Trying to get dressed Mike falls 47
Mary Ludlum CONDUCTING REVIEWS: 5 WHYS, ROOT CAUSE, CAUSE/EFFECT STATEMENTS 48
5 Whys Why did event happen? Because of situation/circumstance A Why A? Because of factor B Why B? Because of factor C Why C? Because of factor D Why D? until root cause is reached 49
5 Whys (cont d) Why did you get a flat tire? Because I ran over nails on the garage floor. Why did you run over nails on the garage floor? Because the box of nails on the shelf was wet; the box fell apart and the nails from the box fell onto the floor. Why was the box of nails wet? Because there was a leak in the roof and it rained last night. 50
The Jefferson Memorial and the 5 Whys Problem: The stone exterior of the memorial was deteriorating due to the use of high pressure washers to clean the walls. Solution: Put up nets to deter birds from getting too close to memorial. https://www.youtube.com/watch?v=v9n6l0gwtik 51
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The Jefferson Memorial and the 5 Whys Problem: The stone exterior of the memorial was deteriorating due to the use of high pressure washers to clean the walls. Solution: Decrease the time spotlights shine on the building at night. https://www.youtube.com/watch?v=v9n6l0gwtik 53
Importance of Drilling Down At first glance, solutions seem obvious Stone is deteriorating from frequent washing Wash Memorial less frequently Replace damaged stone Obvious solutions may have major drawbacks and may not address the root cause of the problem Washing less frequently may deter paying visitors Replacing the damaged stone is expensive and doesn t address the issue of stone deterioration 54
Cause Statement Tips Describe the system rather than an individual Use full sentences or phrases State in Because...then format if possible Do not use generalized categories (e.g., communication ) as a cause Avoid words like failed or inadequate 55
Cause Statement Examples Cause Statement: Attending nurse had inadequate training. Revised Cause Statement: Because Hospital A does not see many cases of procedure X, staff were not familiar with how to safely perform the procedure. 56
Cause Statement Examples Cause Statement: Epic and the lab computer system do not interface well. Revised Cause Statement: Because our EMR and lab computer systems are not fully integrated, the lab results did not get entered into the patient s medical record. 57
Cause Statement Examples Cause Statement: Staff did not communicate with one another about resident s fall risk. Revised Cause Statement: Because there was not a place within the resident s record to document fall risk, staff were unaware that the patient needed additional assistance. 58
Examples of Root Causes? 59
Charlie s Story: Root Cause Exercise: 15 minutes Use the 5 Whys identify the root cause(s) of this event Write a cause statement for one root cause Problem Statement Why Why Why Cause Statement Mike fell while getting dressed Mike stood up while unassisted Mike asked nurse for privacy and wife went to get the car Mike uncomfortable with dressing in front of nurse Because Mike was uncomfortable getting dressed in front of the nurse, he was unassisted while he got dressed 60
Lynn Trexler DEVELOPING STRONG AND EFFECTIVE ACTION PLANS 61
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Action Plan Strengths 63
Strong Action Plan? Choose actions which address each root cause Ask: Will this action eliminate or greatly reduce the likelihood of an event? Consider actions that do not depend on staff memory to do the right thing Provide tools to help staff to remember or promote clear communication 64
Eliminate/Reduce Distractions Designate a no-interruption zone/signal during critical times. 65
Simplify Processes Simplify processes by identifying factors causing medication errors. Are there redundancies? Do they add value? 66
Leadership Support in SPEAK UP! Develop a Red Rule to Speak Up! when a time out is not performed or not performed adequately. Patient Safety 67
Standardize Practice Safe Surgery Checklist 68
Standardize Equipment 69
Standardize Room Set Up 70
Forcing Function 71
Education-Related Action Plans Review six rights of medication at staff meeting. 72
Education-Related Action Plan All new staff will have specific training and return competency regarding EMR entry and use. 73
Communication-Related Action Plans Remind patient with dementia to use call light. 74
Communication-Related Action Plans A two-way read back/hear back confirmation will be documented with every verbal order. 75
Communication-Related Action Plans TeamSTEPPS tools CUS Briefing Check Back Limited English Proficiency module http://www.ahrq.gov/professionals/education/curriculumtools/teamstepps/lep/videos/opportunity/index.html 76
Stop the Line: CUS http://www.ahrq.gov/professionals/education/curriculumtools/teamstepps/lep/videos/cuswords/index.html 77
Briefs Planning Form the team Designate team roles and responsibilities Establish climate (psychological safety) and goals Engage team in short- and long-term planning http://www.ahrq.gov/professionals/education/curriculumtools/teamstepps/lep/videos/briefing/index.html 78
Check-Back Is http://www.ahrq.gov/professionals/education/curriculumtools/teamstepps/lep/videos/checkback/index.html 79
Communication-Related Action Plans Success video for Mr. Hernandez http://www.ahrq.gov/professionals/education/curriculumtools/teamstepps/lep/videos/success/index.html 80
Examples of System Level Action Plans? 81
Making Action Plans Stronger Weaker Patient candidate selection policy and procedure (P&P) requires conversation between anesthesiologist and surgeon. Review P&P with all providers including locums. Stronger Require sign-off that indicates both the anesthesiologist and surgeon who will be performing surgery have agreed on patient selection before outpatient surgery is scheduled. (Forcing function) 82
Making Action Plans Stronger Weaker Remind nurse to follow six medication rights. Stronger Have resident teach back what medications they are prescribed and what they have received from nurse before taking medications (for residents that are able to understand and communicate this safely). (Redundancy, Teach Back) 83
Making Action Plans Stronger Weaker Remind staff to double check medication orders and medication administration record (MAR). Stronger When entering new orders, have independent verification by two different staff of original order and what was entered in the EMR and MAR. (Independent verification) 84
Making Action Plans Stronger Weaker Keep talking to a minimum; keep volume in pharmacy down so it is easier to communicate. Wait for pharmacist to be ready to listen. Stronger Have pharmacist give a distinct signal or communication when they are ready to listen without interruption (e.g., Ready! ). (Eliminate/reduce distraction) 85
Making Action Plans Stronger Weaker Direct care staff to ensure intended alarms are activated prior to leaving the room. Stronger Include check of intended alarms on hourly rounding tool. (Checklist) 86
Where Do You Get Ideas for Action Plans? Patients/residents/families Front line staff Clinical guidelines and best practice Other facilities Toolkits http://oregonpatientsafety.org/news-events/past-events/strengthening-aeinvestigations/1663/ 87
In Summary Address the identified root cause/contributing factors Focus on systems, not on individuals Be specific and concrete Include stronger actions, which are more likely to eliminate or greatly reduce the likelihood of an event (see Action Plan Strengths in your packet) 88
Action Plan Exercise Take 5 minutes to complete the Action Plan Exercise in your packet. 89
Charlie s Story: Action Plan Exercise: 15 minutes With your group, brainstorm and write on the easel two action plans that you would do related to your root cause and contributing factors. 90
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Melissa Parkerton IMPLEMENTATION STRATEGIES 92
Aims Measurement Change ideas Testing ideas before implementing changes 93
What Are We Trying to Accomplish? Aim Statement By when? For whom? How much do we want to improve? Aim statement: Reduce hospital-associated CDI on med-surg unit by 10% in 2016 as compared to 2015. 94
How Will We Know That a Change is an Improvement? Outcome Measures. What is the result? Process Measures. Are the parts/steps in the system performing as planned? Balancing Measures. Are changes that improve one part of the system causing new problems in other parts of the system? 95
How Will We Know That a Change is an Improvement? Measures Outcome % of patients with HA CDI Process Hand hygiene compliance rates % of patient encounters with full contact precautions Balancing Gown/glove costs per month Patient satisfaction 96
Every Improvement is a Change, But Not Every Change is an Improvement 97
What Changes Can We Make? Where can you find change ideas? Literature Clinical guidelines Toolkits From each other From other healthcare facilities 98
What Changes Can We Make? Establish secret shoppers Transparent data sharing Create an environmental services occupied room checklist Implement new isolation STOP signs Bleach for terminal cleaning 99
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Conducting Small Tests What is our aim (goal)? Reduce hospital-associated CDI on med-surg unit by 10% in 2016 as compared to 2015. What will we measure? % of patients with HA CDI Hand hygiene compliance rates Patient satisfaction rates What will we change? Establish secret shoppers Implement new isolation STOP signs 101
PDSA Cycle What changes will you make? Will you adopt, adapt or abandon your plan? Objective, questions and predictions (why) Plan to carry out the cycle (who, what, where, when) Complete the analysis of the data Compare data to predictions Summarize what was learned Carry out the plan Document problems and unexpected observations Begin analysis of the data 102
Repeated Use of the Cycle A P S D Changes that result in improvement Implementation of change Hunches, theories, ideas A P S D Very small scale test Follow-up tests Wide-scale tests of change 103
Why Test? Increase the belief that the change will result in improvement Predict how much improvement can be expected from the change Learn how to adapt the change to conditions in the local environment Evaluate costs and side-effects of the change Minimize resistance upon implementation 104
Guidance for Testing a Change Test on a small scale and collect data over time Build knowledge sequentially with multiple PDSA cycles for each change idea Include a wide range of conditions in the sequence of tests Avoid the cookie cutter approach People who touch the patients are the feasibility filters for changed processes 105
Understanding the PDSA Process The Threaded Rod Exercise 106
Threaded Rod Rules The rod is your organization The wingnuts are your patients/residents Every patient/resident must safely traverse the rod They all start off the rod They all must be safely caught at the end Every member of your team must touch the process no observers When prompted, you will begin When you re done, raise your hand Goal: Move your patients through your system as quickly and safely as possible 107
The Threaded Rod Exercise Know your baseline 108
How Did it Go? Take a couple minutes to brainstorm as a group What went well? What do you want to improve? What will you do differently next time? 109
Creating Meaningful Aim Statements Know your baseline or establish a baseline Set stretch goals that are realistic and time bound Set smaller goals with shorter timelines that build towards long term goals Clearly describe your aim so it is easy to follow 110
PDSA Worksheet Fill out your PDSA Exercise sheet. By the end of Q2, we will reduce our wingnut travel time by 20% with 0 dropped wingnuts. 111
PDSA Worksheet Fill out your PDSA Exercise sheet. By the end of Q2, we will reduce our wingnut travel time by 20% with 0 dropped wingnuts. # of seconds for all three wingnuts to traverse the rod decreases 20% End of Q2 # of dropped wingnuts 0 errors End of Q2 One person will stabilize the rod One person responsible for catching all wingnuts Melissa Lynn 112
Threaded Rod Exercise First Test of Change Take a minute to plan as a group Identify your team roles When instructed, ensure that all wingnuts traverse the entire rod as quickly and safely as possible 113
The Threaded Rod Exercise First Test of Change 114
How Did it Go? Take a couple minutes to brainstorm as a group What went well? What do you want to improve? What will you do differently next time? 115
PDSA Worksheet Fill out your PDSA Exercise sheet. By the end of Q2, we will reduce our wingnut travel time by 20% with 0 dropped wingnuts. # of seconds for all three wingnuts to traverse the rod decreases 20% End of Q2 # of dropped wingnuts Reduced 0 errors time by 10%, End dropped of Q2 one wingnut, and almost dropped another. One person will stabilize the rod One person responsible for catching all wingnuts Melissa Lynn Adapt 116
What Changes Can We Make? Consider your own experience Is there guidance in the literature? Known best practices? What are your peers doing that seems to be working? 117
PDSA Worksheet One person will stabilize the rod One person responsible for catching all wingnuts Melissa Lynn Time reduced by 10%, dropped one and nearly dropped another Adapt One person holds rod Each team member responsible for one wingnut Melissa Lynn, Mary, Carrie 118
Threaded Rod Exercise Second Test of Change Take a minute to plan as a group Identify your team roles When instructed, ensure that all wingnuts traverse the entire rod as quickly and safely as possible 119
The Threaded Rod Exercise Second Test of Change 120
How Did it Go? Take a couple minutes to brainstorm as a group What went well? What do you want to improve? What will you do differently next time? 121
PDSA Worksheet One person will stabilize the rod One person responsible for catching all wingnuts Melissa Lynn Time reduced by 10%, dropped one and nearly dropped another Adapt One person holds rod Each team member responsible for one wingnut Melissa Lynn, Mary, Carrie Time reduced by 20%, none dropped, very high stress Adapt 122
The Threaded Rod Exercise Third Test of Change 123
The Value of Failed Tests I did not fail one thousand times; I found one thousand ways how not to make a light bulb. Thomas Edison 124
Testing and Implementation Testing: trying and adapting existing knowledge on small scale; learning what works in your system Implementation: making this change a part of the day-to-day operation of the system Would the change persist even if its champion left the organization? 125
Lack of Structured Approach to Improvement It s the equivalent of wanting to play the guitar, not taking lessons, failing to practice regularly, and then getting rid of the guitar because you can t play it. 126
Putting It Back Together Aim Statement + Measures + New Ideas + Testing Changes = IMPROVEMENT! 127
Questions? 128
What s Next: Using PSRP and EDR Submit adverse events to Patient Safety Reporting Program (PSRP) System collects causes and associated action plans Non-identifiable data is shared in aggregate to improve patient safety ASCs, hospitals, nursing facilities, and pharmacies can participate Request a conversation through Early Discussion and Resolution (EDR) Engage in a transparent conversation to reach resolution Events resulting in serious physical injury or death Can be started by a patient or provider Both systems are protected, confidential, and voluntary 129
Resources Available on our website: Patient Safety Resources Patient Safety Glossary Tips for Ensuring a Strong Report 130
More Information Materials from today s event are available at: http://oregonpatientsafety.org/news-events/past-events Contact OPSC: 503-928-6158 psrp@oregonpatientsafety.org 131
Stay Connected Subscribe to our newsletter Follow us on Facebook, Twitter, LinkedIn, Google+ Attend other OPSC events oregonpatientsafety.org 132
"The names of the patients whose lives we save can never be known. Our contribution will be what did not happen to them. And, though they are unknown, we will know that mothers and fathers are at graduations and weddings they would have missed, and that grandchildren will know grandparents they might never have known, and holidays will be taken, and work completed, and books read, and symphonies heard, and gardens tended that, without our work, would have been only beds of weeds." - Donald M. Berwick 133